NovaBridge Biosciences Receives FDA Fast Track Designation for Givastomig in First-Line HER2-Negative Metastatic Gastric Cancer

Registrational Phase 3 Trial Expected to Begin as Early as Q4 2026 Detailed Phase 1b Data Expected to be Presented at a Major Medical Conference in H2 2026 ROCKVILLE, Md., June 16, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive.

GlobeNewsWire • Jun 16, 2026

NovaBridge to Present at the 2026 Jefferies Global Healthcare Conference

ROCKVILLE, Md., May 28, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced that members of the Company's senior management team will participate in the 2026 Jefferies Global Healthcare Conference being held June 2-4, 2026.

GlobeNewsWire • May 28, 2026

NovaBridge to Present at the H.C. Wainwright 4th Annual BioConnect Investor Conference

ROCKVILLE, Md., May 12, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company), a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced that members of NovaBridge's management team will participate in the upcoming H.C.

GlobeNewsWire • May 12, 2026

NovaBridge Appoints Mark Hagler as President and Chief Commercial Officer to Advance Commercial Strategy and Maximize Pipeline Value

Seasoned Biopharma leader bringing deep commercial experience to shape and inform corporate strategy, clinical trial design and business development discussions Strong industry reputation and commercial track record in high-value pharmaceutical markets including oncology and ophthalmology Strengthens NovaBridge's leadership team as the Company advances givastomig, a potential first-in-class Claudin 18.2 x 4-1BB bispecific antibody for first line (1L) gastric cancer, toward registrational pivotal studies and continues to advance VIS-101, purpose-designed, potential best-in-class, dual VEGF-A x ANG-2 inhibitor for wet AMD ROCKVILLE, Md., April 22, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced the appointment of Mark Hagler as President and Chief Commercial Officer.

GlobeNewsWire • Apr 22, 2026

NovaBridge's Givastomig Could Drive A Major Re-Rating

NovaBridge Biosciences remains a high-risk, catalyst-driven biotech, trading near cash value with a focus on pipeline advancement. NBP's lead asset, Givastomig, has shown strong Phase 1b data—75% response rate, 16.9-month PFS, and manageable safety in gastric cancer. Upcoming 2026 Phase 1b data for Givastomig and a potential accelerated approval pathway are critical inflection points for re-rating.

Seeking Alpha • Apr 9, 2026

NovaBridge Reports Full Year 2025 Financial Results and Provides Business Update

ROCKVILLE, Md., April 07, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines, today announced financial results for the full year ended December 31, 2025, and highlighted recent pipeline progress and business updates for its two lead investigational programs, givastomig (Phase 2, directed to gastric cancer), and VIS-101 (Phase 2, targeting wet age-related macular degeneration, or wet AMD).

GlobeNewsWire • Apr 7, 2026

NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer

FDA confirmed givastomig's potential eligibility for an accelerated approval pathway NovaBridge expects to initiate a registrational Phase 3 combination trial as early as Q4 2026, using objective response rate (ORR) as a primary endpoint for accelerated approval Givastomig, a bispecific Claudin 18.2 X 4-1BB antibody, has the potential to be a first-in-class and best-in-class first line (1L) Claudin 18.2 (CLDN 18.2) therapeutic in Her-2 negative (Her2-), CLDN 18.2 positive (CLDN 18.2+), PD-L1-positive (PD-L1+) gastroesophageal cancer (GEC)  ROCKVILLE, Md., March 16, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that based on a productive Type B meeting with the U.S. Food and Drug Administration (the “FDA”) and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig's potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial.

GlobeNewsWire • Mar 16, 2026

Mid-Cap NovaBridge Biosciences Stock Jumps Fueled By Positive Study Data In Eye Disease

NovaBridge Biosciences (NASDAQ: NBP) shares are up on Monday following the announcement of positive topline results from the Phase 2a study of VIS-101, a treatment for retinal vascular diseases.

Benzinga • Mar 9, 2026

NovaBridge Biosciences (NBP) Discusses Phase 2a Clinical Data and Development Plan for VIS-101 in Wet Age-Related Macular Degeneration Transcript

NovaBridge Biosciences (NBP) Discusses Phase 2a Clinical Data and Development Plan for VIS-101 in Wet Age-Related Macular Degeneration Transcript

Seeking Alpha • Mar 9, 2026

NovaBridge and Visara Announce Positive Results from VIS-101 Phase 2a Wet AMD Study

ROCKVILLE, Md., March 09, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, and its subsidiary, Visara, Inc. (Visara), today announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Topline results show that VIS-101 produced rapid, robust and durable treatment responses in wet AMD, with potential best-in-class durability and a favorable safety profile. Wet AMD affects more than 20 million people globally1.

GlobeNewsWire • Mar 9, 2026